A Study of MGD024 in Patients With Relapsed or Refractory Hematologic Malignancies
NCT ID: NCT05362773
Last Updated: 2026-01-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
130 participants
INTERVENTIONAL
2022-07-13
2027-05-31
Brief Summary
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Participants will receive treatment with MGD024 in consecutive 28-day cycles for a study treatment period of up to 12 cycles (approximately 1 year) or until treatment or study discontinuation criteria are met. Response assessments will be performed after Cycle 1 and then after every even numbered cycle starting with Cycle 2 until progression or study treatment discontinuation. Participants will be checked for side effects throughout the study.
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Detailed Description
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Conditions
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Study Design
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NA
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Dose Escalation
Escalating doses of MGD024 will be assigned based on safety and tolerability of the previous dose level.
MGD024
MGD024 is a CD123 x CD3 bispecific DART® molecule designed to target CD123-expressing leukemic cells for elimination by CD3-expressing T lymphocytes.
Interventions
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MGD024
MGD024 is a CD123 x CD3 bispecific DART® molecule designed to target CD123-expressing leukemic cells for elimination by CD3-expressing T lymphocytes.
Eligibility Criteria
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Inclusion Criteria
* Participants with
* primary or secondary acute myeloid leukemia (AML) except acute promyelocytic leukemia,
* primary or secondary myelodysplastic syndrome (MDS) with prognostic score of \>3 and \<20% bone marrow blasts,
* classical Hodgkin lymphoma (cHL),
* chronic myelogenous leukemia (CML),
* b-cell acute lymphocytic leukemia (B-ALL),
* hariy cell leukemia (HCL),
* advanced systemic mastocytosis (ASM), or
* blastic plasmacytoid dendritic cell neoplasm (BPDCM)
* Relapsed after or refractory to at least one prior line of therapy and with no available potentially curative treatment option.
* Evidence of at least 20% of malignant cells with CD123 expression.
* Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.
* Life expectancy of at least 12 weeks.
* Acceptable laboratory values, and heart function.
* Continuing side effects of prior treatment are mild
* Women and men of childbearing potential must agree to use highly effective forms of contraception throughout the study through 4 months after the last dose of MGD024.
Exclusion Criteria
* Known involvement of central nervous system (CNS) by the disease under investigation.
* History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the patient's participation for the full duration of the trial, or is not in the best interest of the patient.
* Systemic anti-cancer therapy, investigational therapy, corticosteroids or other immune suppressive drugs within 14 days of first dose
* Vaccination with any live virus vaccine within 4 weeks prior to first dose. Inactivated annual influenza and SARS-CoV-2 vaccination are allowed.
18 Years
ALL
No
Sponsors
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MacroGenics
INDUSTRY
Responsible Party
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Principal Investigators
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Denise Casey, M.D.
Role: STUDY_DIRECTOR
MacroGenics
Locations
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Colorado Blood Cancer Network
Denver, Colorado, United States
University of Maryland, Greenbaum Comprehensive Cancer Center
Baltimore, Maryland, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
START - Midwest
Grand Rapids, Michigan, United States
Washington University School of Medicine
St Louis, Missouri, United States
Duke University Medical Center
Durham, North Carolina, United States
South Austin Medical Center
Austin, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Eric Winer, MD
Role: primary
Other Identifiers
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CP-MGD024-01
Identifier Type: -
Identifier Source: org_study_id
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